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Phase 2

IanalumabTwo-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06293365

Conditions

Sjögrens Disease

Systemic Lupus Erythematosus

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

VAY736 1ml PFS

VAY736 2 ml PFS

VAY736 2ml AI

Study Details

Brief summary:

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).

A second cohort will be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.

Conditions

Sjögrens Disease

Systemic Lupus Erythematosus

Rheumatoid Arthritis

Study ID

NCT06293365

Start date

Jul 2, 2024

Status verified date

Jul, 2025

Completion date

Mar 16, 2029

Anticipated

Primary completion date

Aug 29, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Key Inclusion criteria:

Signed informed consent must be obtained before any assessment is performed.
Male and female patients aged 18 years to 70 years (inclusive).
Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2 at screening.
Diagnosed with RA, SjD and/or SLE as determined by the investigator.
Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator.
Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment.
Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study.

Key Exclusion criteria:

Use of prohibited therapies.
Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection.
Plans for administration of live vaccines during the study period.
Uncontrolled co-existing serious disease.
Pregnant or nursing (lactating) women.
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug.
US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse with women of child-bearing potential while taking study treatment.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Sequence 1 + Thigh

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh

(1 x 2 mL) AI in ETP in Thigh/ Abdomen

experimental: Cohort 1: Sequence 1 + Abdomen

Patients randomized to receive injection

1. X 2 mL) AI in TP1 in Abdomen
2. x 1 mL) PFS in TP2 in Abdomen

(1 x 2 mL) AI in ETP in Thigh/ Abdomen

experimental: Cohort 1: Sequence 2 + Thigh

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh

(1 x 2 mL) AI in ETP in Thigh/ Abdomen

experimental: Cohort 1: Sequence 2 + Abdomen

Patients randomized to receive injection

1. X 2 mL) AI in TP1 in Abdomen
2. x 1 mL) PFS in TP2 in Abdomen

(1 x 2 mL) AI in ETP in Thigh/ Abdomen

experimental: Cohort 2: Sequence 1 + Thigh

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh

1. X 2 mL) PFS in TP2 in Thigh
2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

experimental: Cohort 2: Sequence 1 + Abdomen

Patients randomized to receive injection

1. X 2 mL) PFS in TP1 in Abdomen
2. x 1 mL) PFS in TP2 in Abdomen

(2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

experimental: Cohort 2: Sequence 1 + Upper Arm

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Upper Arm

1. X 2 mL) PFS in TP2 in Upper Arm
2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

experimental: Cohort 2: Sequence 2 + Thigh

Patients randomized to receive injection

1. X 2 mL) PFS in TP1 in Thigh
2. x 1 mL) PFS in TP2 in Thigh

(2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

experimental: Cohort 2: Sequence 2 + Abdomen

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Abdomen

1. X 2 mL) PFS in TP2 in Abdomen
2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

experimental: Cohort 2: Sequence 2 + Upper Arm

Patients randomized to receive injection

1. X 2 mL) PFS in TP1 in Upper Arm
2. x 1 mL) PFS in TP2 in Upper Arm

(2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Interventions

VAY736 1ml PFS

Solution for injection.

VAY736 2 ml PFS

Solution for injection

VAY736 2ml AI

Solution for injection.

Primary outcome measure

Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab [ Time Frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24). ]
Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab [ Time Frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24). ]
Cohort 2: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab [ Time Frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24). ]
Cohort 2: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab [ Time Frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24). ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Pinnacle Research Group Llc

Recruiting

Anniston, Alabama, United States, 36207

Contacts

Jamie Bush

256-236-0055 jbush@pinnacletrials.com

Principal Investigator:

Vishala L Chindalore

Conquest Research

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Liz Gomez

407-353-2402 liz.gomez@conquestresearch.com

Principal Investigator:

Anand Patel

Indiana Univ School of Dentistry

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Parul Patel

317-274-8822 paripatel@iu.edu

Principal Investigator:

Domenick Zero

Ochsner Health System

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Blanche Smith

225-761-5607 blanche.smith@ochsner.org

Principal Investigator:

Saravanan Thiagarajan

Ahmed Arif Medical Research Center

Recruiting

Grand Blanc, Michigan, United States, 48439

Contacts

Aya Elbakheet

810-953-8700 aya@aamrc.net

Principal Investigator:

Ali Karrar

Paramount Med Rsrch and Consult LLC

Recruiting

Middleburg Heights, Ohio, United States, 44130

Contacts

Denine Ryan

440-826-0742 deniner64@gmail.com

Principal Investigator:

Isam Diab

RAO Research LLS

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Contacts

Lauren Warr

405-608-8060 lwarr@raoklahoma.com

Principal Investigator:

Latisha Heinlen

Altoona Center for Clin Res

Recruiting

Duncansville, Pennsylvania, United States, 16635

Contacts

Janae Roland

janaeroland@altoonaresearch.com

Principal Investigator:

Alan J Kivitz

West Tennessee Research Institute

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

Sherry Wiggins

731-664-7824 swiggins@arthritisclinic.org

Principal Investigator:

Jacob A Aelion

Novel Research LLC

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Cecilia Valerio

cvalerio@introscienceresearch.net

Principal Investigator:

Wajeeha Yousaf

Uni of Texas Health Science Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

210-617-5111

Principal Investigator:

Agustin Escalante

Novartis Investigative Site

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M5T 2S8

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 29, 2025

Last verified

Jul, 2025

Keywords

Sjögrens Disease (SjD)
Systemic lupus erythematosus (SLE)
Rheumatoid Arthritis (RA)
Pharmacokinetic (PK) comparability
2 mL auto-injector (AI)
1 mL pre-filled syringe (PFS)
2 mL pre-filled syringe (PFS)
VAY736
ianalumab
B cell depletion
Area under the curve (AUC)
Cmax

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2025-07-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.